FDA Lifts Hold on Intellia’s MAGNITUDE Phase 3 Trial for 1,200 Patients
Intellia shares jumped Monday after FDA lifted the clinical hold on its MAGNITUDE Phase 3 trial for nexiguran ziclumeran in ATTR-CM patients, paused in October over Grade 4 liver enzyme spikes. The agency cleared 1,200-patient enrollment under new liver monitoring, steroid and exclusion measures.
1. FDA Removes Clinical Hold on MAGNITUDE Phase 3
The FDA lifted the clinical hold on Intellia’s MAGNITUDE Phase 3 trial for nexiguran ziclumeran in ATTR-CM patients, initially paused in October 2025 following a Grade 4 liver transaminase elevation and increased bilirubin in a dosed participant.
2. New Mitigation Measures and Trial Details
Intellia and the FDA agreed on enhanced liver function monitoring protocols, guidance for short-term steroid administration upon enzyme elevations and exclusion of patients with recent cardiovascular instability or ejection fraction below 25%. The MAGNITUDE trial aims to enroll approximately 1,200 ATTR-CM patients, while MAGNITUDE-2 will include about 60 ATTRv-PN subjects.
3. Share Price Reaction and Technical Outlook
Shares rose 8.85% on Monday, extending a 20% gain over the past 12 months and moving closer to a $16.50 resistance level, with support at $14.00. Technical indicators show an RSI of 50.00 in neutral territory and a MACD of 0.10 below its 0.15 signal line, signaling mixed momentum.
4. Analyst Ratings and Price Targets
The stock carries a consensus Buy rating and a $19.73 average price target. Recent analyst actions include maintained Buy with a $26.00 target and an increased target to $25.00.